"On the merits, the Orbec package was apparently very weak. BSR ripped it up and down."
If you watched the panel meeting you wouldn't think it was weak so where did the apparently come from. The fact that BSR ripped it up and down doesn't mean it deserved to be ripped. He was trying to read the minds of the FDA. All you can do is look at their actions in each case.
"Yet top line it seemed to help a grievously ill group. It would be nice to think that someone at FDA saw through the package to real patient benefit and pointed out a path for DORB to get Orbec approved. Nice, but totally out of character. Chances are we're being fooled by management on this new submission - fitting the essential theme of Dew's entire board."
If you watched the panel meeting you would see the comments that Richard Pazdur made and see that he saw the benefits of the drug at the meeting. I believe that before he saw the data at the meeting he was convinced that the drug was shit, and a thirty cent bulletin board company was trying to pull a fast one.
I believe the drug will be approved because of what I saw at the panel meeting and have bought more since the extension because I think the risk/reward is tremendous and the risk/benefit of the drug is all benefit and no risk
weak data package? read this
The NDA filing is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec® conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. Although orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time to treatment failure through Day 50 (p-value 0.1177),
The treatment failure rate at 50 days had a p-value of .0515. I don't know why they don't include that
orBec® did achieve statistical significance in other key secondary endpoints such as median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
In the Phase 2 study, the primary endpoint was the clinically relevant determination of whether GI GVHD patients at Day 30 were or were not able to consume at least 70% of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administered in the hospital. The treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec® and placebo groups respectively, achieving a statistically significant p-value of 0.02. Additionally, the treatment response at Day 40 was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec® and placebo groups respectively, achieving a statistically significant p-value of 0.007.
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